RecruitingNot ApplicableNCT04166695

Clinical Performance of Long-span Fixed Partial Dentures

Clinical Performance of Long-span All-ceramic or Metal-ceramic Fixed Partial Dentures on Implants and/or Natural Teeth


Sponsor

University Hospital Heidelberg

Enrollment

40 participants

Start Date

Jan 9, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

Tooth-coloured fixed restorations are becoming increasingly popular with patients and dentists. If high-strength all-ceramics such as zirconia are used as the restoration material, a maximum of two adjacent missing teeth can be replaced with the aid of fixed partial dentures (FPDs). For the replacement of a missing anterior or posterior tooth by FPDs, a very good clinical performance similar to that of metal-based, ceramic-veneered restorations can be expected. However, evidence-based statements on the clinical performance of long-span all-ceramic FPDs are difficult because there are only very few studies on this topic, which are also inhomogeneous with regard to the study conditions. Randomized studies to compare monolithic (consisting only of the high-strength framework material) or partially veneered (weaker veneering ceramics in esthetically relevant tooth areas) all-ceramic and classic (completely veneered) metal-ceramic FPDs are lacking. The aim of the current explorative, prospective, randomized, two-arm clinical interventional study is therefore to compare the clinical performance of long-span FPDs (≥ 4 Pontics) made of monolithic / facially veneered zirconium dioxide with a gold standard (completely veneered cobalt chromium (CoCr)-based FPDs). Forty patients will be recruited. Once all inclusion criteria have been established, including the signed informed consent of the patients informed of the content, effort, advantages and disadvantages of the study, patients are assigned to the two study groups by stratified block randomization (main strata: tooth-supported / (tooth-)implant-supported). After placement of the restorations, follow-up examinations are performed after 1 week (baseline) and after half a year, one year, two years and three years. In addition to the main target criterion (veneering defects), further complications (related to FPDs or supporting tissues / structures) and parameters of oral health are recorded. Depending on the distribution and structure of the data, parametric and non-parametric statistics are used. Group differences with respect to the main target criterion ceramic defects are to be investigated by log-rank and chi-square tests. The significance level is set at α \< 0.05. Since this is an explorative study, all p-values are descriptive.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the 3-year clinical performance of long-span fixed partial dentures (dental bridges that span two missing teeth side by side) made with modern dental materials. Traditionally, replacing two adjacent missing teeth with a fixed bridge required either a long-span design that was considered risky or implants. Improvements in dental materials and adhesion techniques may now make long-span bridges more reliable, offering patients a less invasive alternative to dental implants. Participants will be randomly assigned to receive one of the bridge designs being compared, and their dental health, bridge function, and patient satisfaction will be tracked over 3 years at regular check-up appointments. You may be eligible if: - You are at least 18 years old with full legal capacity - You have two adjacent missing posterior teeth (premolars or molars) that need replacement - Your supporting teeth are healthy with adequate periodontal status - You are willing to attend follow-up appointments over 3 years You may NOT be eligible if: - You are pregnant or breastfeeding - You have severe bruxism (tooth grinding, more than 4 episodes per night) - Your supporting teeth have reduced crown height, deep periodontal pockets, furcation involvement, or significant mobility - You have untreated root canal problems in the supporting teeth - You have known allergies to the dental materials used in the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMonolithic / facially veneered zirconia fixed partial denture

Participant receives one monolithic / facially veneered zirconia fixed partial denture retained by either teeth, implants or teeth and implants for the replacement of two neighbouring posterior teeth.

DEVICECompletely veneered CoCr fixed partial denture

Participant receives one completely veneered CoCr fixed partial denture retained by either teeth, implants or teeth and implants for the replacement of two neighbouring posterior teeth.


Locations(1)

Department of Prosthodontics, University Hospital Heidelberg, University of Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

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NCT04166695


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